Last updated: March 1, 2026
What Is the Drug Identified by NDC 00536-1213?
NDC 00536-1213 is designated for Atripla, a fixed-dose combination product containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate. Approved by the FDA in 2006, it targets HIV-1 infection. It is indicated for adult and pediatric patients, typically as part of antiretroviral therapy (ART).
Market Landscape
Current Market Size
The global HIV treatment market was valued at approximately $24 billion in 2022. Nucleoside reverse transcriptase inhibitors (NRTIs), including tenofovir and emtricitabine, account for a significant share, with efavirenz included in earlier regimens.
Key Competitors
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Genvoya (Viread, Emtriva, Vitekta, Strilba): Combines tenofovir alafenamide with other antiretrovirals.
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Biktarvy: Integrates bictegravir with emtricitabine and tenofovir alafenamide.
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Dovato: Combines dolutegravir and lamivudine for simplified therapy.
Patent Status and Regulatory Environment
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Patent Expiry: The original patent for efavirenz expired in 2018 in the U.S. but was extended via exclusivity periods until 2024 for some formulations.
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Generics: Multiple generic versions of efavirenz and the combination are available since 2018, impacting pricing and market share.
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Regulatory Trends: Increasing approval of integrase inhibitor-based regimens, which diminish the market share for efavirenz-based drugs like Atripla.
Pricing Trends and Projections
Historical Pricing Data
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Brand-Name Atripla (2010-2017): Wholesale acquisition cost (WAC) ranged from $1,100 to $1,400 per month.
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Generics (2018 onward): Prices dropped sharply following patent expiration, with current WAC around $200-$400 per month, depending on formulation and distributor.
Current Pricing
| Formulation |
Approximate WAC (USD/month) |
Notes |
| Branded Atripla |
$1,200 - $1,400 |
Until patent expiration |
| Generic efavirenz-based drugs |
$200 - $400 |
Dominant in the market post-2018 |
Price Projection (2023-2028)
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Short-term (1-2 years): Prices for generic efavirenz-based treatments will stabilize around $200-$300 per month, driven by competitive generics and insurance negotiations.
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Medium-term (3-5 years): Entry of new formulations and updates (e.g., long-acting injectables) may reduce demand for oral fixed-dose combinations like Atripla, pushing prices down further or transitioning to alternative therapies.
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Long-term (5+ years): Market share for efavirenz-based regimens may decline notably due to newer drugs, with prices for remaining formulations holding steady or decreasing marginally.
Market Dynamics Impacting Price
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Generic Competition: Major factor decreasing prices since 2018, stabilizing around current levels.
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Patent Exclusivity Extensions: May temporarily sustain higher prices, but external pressures limit such effects.
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Therapeutic Shifts: Transition toward integrase strand transfer inhibitors reduces the market for efavirenz-based drugs.
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Insurance Coverage: Payers tend to favor lower-cost generics, further constraining prices.
Strategic Considerations
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For Manufacturers: Opportunities lie in developing long-acting injectables or novel combinations that could command premium pricing.
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For Investors: The decline in demand for efavirenz-containing drugs diminishes future revenue prospects. Focus on injectable and novel therapies offers higher growth potential.
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For Healthcare Providers: Cost-effective generics are now the standard, reducing profit margins for branded products like Atripla.
Summary
| Aspect |
Data |
| Current Price |
$200 - $400/month for generics; $1,200 - $1,400/month historically for branded Atripla |
| Patent Expiration |
2018 (U.S.), with market fully transitioned to generics |
| Market Trends |
Declines in oral efavirenz-based therapy, growth in alternative regimens |
| Future Price Trajectory |
Stabilization around $200-$300/month; potential further decline or market exit |
Key Takeaways
- The market for NDC 00536-1213 (Atripla) has shifted towards generic efavirenz-based regimens since 2018, leading to significant price reductions.
- Future demand for efavirenz-based oral products will likely decrease as newer therapies, especially injectable regimens, gain prominence.
- Price projections indicate stabilization at lower levels, with minimal upside absent strategic repositioning or formulation innovation.
- Patent and exclusivity protections no longer significantly impact pricing; market dynamics favor generics.
- Investment and R&D should focus on innovative, long-acting antiretrovirals rather than traditional oral regimens.
FAQs
1. Will the price of Atripla increase again?
Unlikely. Patent expiration and market competition favor lower prices. Only new formulations or delivery methods might sustain or increase pricing.
2. Are any new formulations of efavirenz or similar drugs in development?
Yes. Long-acting injectable formulations of efavirenz are under clinical evaluation, which may alter current market dynamics.
3. How do insurance companies influence the pricing of generic efavirenz drugs?
Insurance providers prefer cost-effective generics, exerting downward pressure on prices through formulary decisions and negotiations.
4. What are the main competitors replacing Atripla?
Integrase inhibitor-based regimens like Biktarvy and Dovato are replacing efavirenz-based treatments due to better tolerability and efficacy.
5. What is the long-term outlook for efavirenz-based therapies?
The outlook is declining; these therapies face obsolescence as newer, more effective, and better-tolerated options become standard.
References
[1] U.S. Food and Drug Administration. (2023). Atripla (efavirenz, emtricitabine, tenofovir disoproxil fumarate) Film-Coated Tablets, for Oral Use. Retrieved from https://www.fda.gov
[2] IQVIA. (2022). Pharmaceutical Market Reports.
[3] Centers for Disease Control and Prevention. (2022). HIV Treatment Guidelines.
[4] Evaluate Pharma. (2023). HIV Market & Pricing Trends.
[5] World Health Organization. (2023). HIV/AIDS Data and Treatment Trends.
